Nutritive Effects of a Cow's Milk Based Formula Fed to Yo... | NCT02776592

Studies
Nutritive Effects of a Cow's Milk Based Formula Fed to Young Children

NCT02776592

Sponsor

Mead Johnson Nutrition

Status

Completed

Last Update Posted

Mar 16, 2017Actual

Enrollment

199Actual

Phase

Not Applicable

Conditions

Child Nutrition Sciences

Interventions

Cow's milk-based formula with added nutrients
Cow's milk-based formula

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 20, 2016Actual

Primary Completion Date

Dec 23, 2016Actual

Completion Date

Dec 23, 2016Actual

First Submitted Date

May 12, 2016

First Submission Date that Met QC Criteria

May 17, 2016

First Posted Date

May 18, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 14, 2017

Last Update Posted Date

Mar 16, 2017Actual

Name	Class
Federal University of Bahia	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study aims to determine if a cow's milk-based formula with added nutrients has an effect on memory, reaction time, strategy or other cognitive development indicators in children 4-5 years of age.

Detailed Description

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

199Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental	Experimental	A cow's milk-based formula with added nutrients	Other: Cow's milk-based formula with added nutrients
Control	Active Comparator	A cow's milk-based formula	Other: Cow's milk-based formula

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cow's milk-based formula with added nutrients	Other		Experimental
Cow's milk-based formula

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Working Memory Capacity	Recall of variable sequences	Up to 24 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change in Motor Response Speeds		Up to 24 weeks
Change in Mental Response Speeds		Up to 24 weeks
Change in Retention of Visual Information

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Health child, 4-5 years of age
Born as full-term (Gestational age of 37-42 weeks)
Consumed cow's milk or a cow's milk-based beverage during the 48 hours prior to the baseline visit
Parents or legal guardian agrees not to feed child any food products or supplements containing probiotics or prebiotics
Signed informed consent

Exclusion Criteria:

History or known or suspected cow milk protein intolerance
Child who has received any food product ot supplement containing probiotics or prebiotics (with the exception of yogurt) in the 15 days prior to the baseline visit
Serious concurrent illness that will interfere in the general management of the child
History of underlying metabolic or chronic disease, congenital malformation, or immunocompromised
Child's z-score of weight for height at baseline is < -3 according to WHO criteria

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

5 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jon Vanderhoof, M.D.	Mead Johnson Nutrition	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Center Fima Lifshitz - Federal University of Bahia		Salvador	Estado de Bahia		Brazil

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided